Catamenial tampon-and-applicator systems referred herein to a combination of a tampon applicator and a tampon housed in the applicator, to be self-used by a user to insert the tampon into the vagina to absorb menstrual fluid to prevent leakage of the fluid from the vagina. Commercial tampons are rated by their capacity to absorb and hold a certain amount of fluid, defined by the industry standards regulating commercial labeling of the tampons, dividing them into several categories, such as “junior,” “regular,” “super,” and the like, by a standard Syngyna Absorbency test method FDA 21 CFR 801.430
However, some tampons, regardless of their rated capability to absorb and hold fluid, fail to prevent leakage before the tampon reaches its rated absorbent capacity, allowing the menstrual fluid to bypass the tampon along vaginal walls. This problem has been known as a premature leakage. Typically in the industry, the premature leakage problem has been addressed by improving various performance characteristics of the tampons, for example, the ability of the tampons to absorb menstrual fluid faster and to swell faster inside the vagina in order to prevent menstrual fluid from bypassing the tampon along the vaginal walls. However, despite such product improvements, which typically require considerable cost, most tampons will still fail to prevent premature leakage, i.e., before they become saturated with the rated amount of the absorbed liquid.
In this respect, it has been surprisingly discovered by the applicants that the instances of premature leakage were substantially reduced when panelists were using tampon-and-applicator systems discovered by the applicants and disclosed in the patent applications (P&G case numbers 9660, 9661, 9662, 9663 and 9664) filed Jun. 4, 2004 coincidentally with the instant patent application and hereby incorporated by reference herein. Coronal MRI images of the panelists using the tampon-and-applicator systems discovered by the applicants revealed that the tampons were disposed within a certain area of the vagina that preferably does not extend beyond the cervix. These images were different from the MRI images of the panelists using the currently marketed tampon-and-applicator systems, deploying the tampons substantially beyond the cervix such that the forward portion of the tampon is substantially posterior of the frontal area of the cervix, thus, resulting in only a portion of the tampon (versus the hole tampon, as discovered by the applicants) being within the preferred area defining the target positioning.
This target positioning has been identified by the applicants as a “low placement positioning” disclosed in the patent applications referenced above (P&G case numbers 9660, 9661, 9662, 9663 and 9664) filed Jun. 4, 2004 coincidentally with the instant patent application and hereby incorporated by reference herein.
Referring to the MRI images noted above, and represented in FIGS. 1 and 2. FIG. 1 is a coronal MRI image of a tampon user having a tampon in the vagina, inserted by the user using a typical commercial tampon-and-applicator system. In comparison, FIG. 2 is a coronal MRI image of a tampon user having a tampon in the vagina, inserted by the user using a tampon-and-applicator system of the present invention.
In FIG. 1, a tampon 10 is inserted substantially deeper in the vagina than a tampon 10A in FIG. 2. The deeper insertion of the tampon 10 results in deflecting of the leading end 11 of the tampon 10 by the cervix 18, specifically by the frontal area 19 of the cervix 18 (deflecting the leading end 11 of the tampon 10 to the left, as shown in FIG. 1, or to the right, depending on the anatomy of the user), and in having the leading end 11 of the tampon 10 being disposed substantially posterior of the frontal area 19 of the cervix 18.
In comparison to FIG. 1, FIG. 2 demonstrates the most preferred position of the tampon 10A according to the present invention, when the leading end 11 of the tampon 10A is disposed anterior of the frontal area 19 of the cervix 18. It should be noted, as will be disclosed in more detail below, that the “lower placement position” discovered by the applicants can include instances when the leading end 11 of the tampon 10A is posterior, but only slightly, of the frontal area 19 of the cervix 18.
The importance of positioning a tampon in relation to the cervix creates a need for in vitro testing capability enabling testing and studying the performance of tampons disposed inside an in vitro apparatus in relation to a cervix-representing element of the in vitro apparatus. However, the above need is not addressed in the art of in vitro testing of catamenial products, including the Syngina test referenced above. Therefore, there is a need for a novel method and apparatus for in vitro testing the tampons disposed in relation to a cervix-representing element. Further, there is a need for a novel method and apparatus for in vitro testing of tampon-and-applicator systems deploying the tampons into the in vitro apparatus comprising the cervix-representing element.